ORG-9700A
Received Mar 25, 2022 · Event occurred Mar 2, 2022
Report 8030229-2022-02681 · MDR key 13913087
Device
Generic name
Receiver Unit
Manufacturer
Nihon Kohden CorporationModel number
ORG-9700ACatalog number
MU-970RA
Lot number
NA
Product problems
- Communication or Transmission Problem
- Patient Data Problem
- Communication or Transmission Problem
- Patient Data Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE CUSTOMER REPORTED THAT THE NURSE IS EXPERIENCING SIGNAL LOSS/DROP OUT ON THE ORG WHEN THE PATIENT GOES TO THE RESTROOM. NO PATIENT HARM WAS REPORTED. NIHON KOHDEN TECHNICIAN REQUESTED MORE DETAILS OF WHEN THIS HAPPENS AND NO RESPONSE FROM THE CUSTOMER. NIHON KOHDEN CONTINUES TO INVESTIGATE THE REPORTED EVENT. NIHON KOHDEN WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
THE CUSTOMER REPORTED THAT THE NURSE IS EXPERIENCING SIGNAL LOSS/DROP OUT ON THE ORG WHEN THE PATIENT GOES TO THE RESTROOM. NO PATIENT HARM WAS REPORTED. NIHON KOHDEN TECHNICIAN REQUESTED MORE DETAILS OF WHEN THIS HAPPENS AND NO RESPONSE FROM THE CUSTOMER.
Description of Event or Problem
THE CUSTOMER REPORTED THAT THE NURSE IS EXPERIENCING SIGNAL LOSS/DROP OUT ON THE ORG WHEN THE PATIENT GOES TO THE RESTROOM. NO PATIENT HARM WAS REPORTED. NIHON KOHDEN TECHNICIAN REQUESTED MORE DETAILS OF WHEN THIS HAPPENS AND NO RESPONSE FROM THE CUSTOMER. MORE INFORMATION RECEIVED IS NIHON KOHDEN TECHNICAL SUPPORT (NKTS) EMAILED A HOSPITAL LAYOUT TO THE CUSTOMER TO VERIFY THE LOCATION OF SIGNAL LOSS. CUSTOMER REQUESTED ONSITE SUPPORT FOR REPORTED ISSUE. THE FACILITY ULTIMATELY DECIDED TO UPGRADE THEIR SYSTEM AS MANY COMPONENTS WERE END OF LIFE AND NOT REPLACEABLE.
Additional Manufacturer Narrative
INCIDENT SUMMARY: ON 03/02/2022, CUSTOMER REPORTED SIGNAL LOSS FOR MU-970RA MONITORING SYSTEM. NO HARM OR INJURY IS ASSOCIATED WITH THE REPORTED ISSUE. CUSTOMER STATED SIGNAL LOSS IS OCCURRING WHEN PATIENT USES RESTROOM. NIHON KOHDEN TECHNICAL SUPPORT (NKTS) EMAILED A HOSPITAL LAYOUT TO THE CUSTOMER TO VERIFY THE LOCATION OF SIGNAL LOSS. CUSTOMER REQUESTED ONSITE SUPPORT FOR REPORTED ISSUE. THE FACILITY ULTIMATELY DECIDED TO UPGRADE THEIR SYSTEM AS MANY COMPONENTS WERE END OF LIFE AND NOT REPLACEABLE. INVESTIGATION SUMMARY: ROOT CAUSE IS UNDETERMINED, AS THE FACILITY DECIDED TO REPLACE THE DEVICE DUE TO THE END-OF-LIFE LETTER FORWARDED BY NKTS. A REVIEW OF TICKETS FOR FACILITY SHOWS NO RECURRENCE OF REPORTED ISSUE. A REVIEW OF THE FACILITY HISTORY SHOWS THAT DURING THE TIME OF THIS TICKET, THERE WERE NO EVENTS WITH THE SAME REPORTED ISSUE.